THE practice of anesthesia and critical care

Transcription

1 EDITORIAL 613 Towards international standardization of the anesthesia machine Steven Dain MD FRCPC THE practice of anesthesia and critical care has become increasingly dependent on medical technology. Almost every day we read articles in journals and newspapers and view on television some aspect of patient safety. It s a trendy topic. Much is written on the fact that we must improve patient safety, but what is really being done about it? We have evolved from the old anesthesia machine which was a hodge-podge assembly of separate components, a Fluotec Mark II vaporizer, Ventimeter ventilator, Dial-a-Flo mixer, oxygen analyzer, low pressure alarm, one-channel electrocardiogram monitor, a manual mercury blood pressure cuff and stethoscope that was bolted together by a handyman in the basement of the hospital. We now have integrated anesthetic gas delivery and monitoring systems and in the future, the automated anesthesia glass cockpit. The term standardization when used in the context of making all equipment similar in design and function is really nowadays a misnomer. It s just a small part of what medical equipment standards writers consider when writing a standard. What we are really trying to do is to write the minimum requirements for the basic safety and essential performance or in other words minimum engineering specifications for medical equipment in general; or for a particular device. Why the minimum, you may ask? Published standards must be sufficiently flexible to provide enough latitude to promote innovation. Standards that require the addition of numerous safety features increase the complexity of a device which may render the device unusable or more prone to failure. The law of diminishing returns takes over once again. An overview of standards development process has been published previously. 1 There is no longer just one safety standard for the anesthesia machine, but a family of safety standards for almost every component of the anesthesia system. A In addition to the particular anesthesia system standard, B there are also additional standards covering radio frequency interference, C software, usability D and alarm systems. E Jeffrey Cooper in his classic article originally published in 1978 and reprinted in 2002 in the journal Quality and Safety in Health Care 2 pointed out that only 14% of critical incidents in anesthesia were related to equipment failure, but 84% of preventable incidents were due to human error. Usability refers to the qualities of a device whereby it is easy to learn, easy to remember, and requires as few steps as possible to perform a task. Usability also implies that the system should have a low error rate and if errors are made, they should be easy to recognize and easy to fix. The device should be pleasant to use and should not frustrate or annoy the user. A IEC Medical Electrical Equipment Part 1: General Requirements for Basic Safety and Essential Performance, 3 rd ed. International Electrotechnical Commission, Geneva B IEC Medical electrical equipment Part 2-13: Particular Requirements for the Safety and Essential Performance of Anaesthetic Systems. International Electrotechnical Commission, Geneva. C IEC Medical electrical equipment - Part 1-2: General tequirements for Safety - Collateral Standard: Electromagnetic Compatibility - Requirements and Tests. International Electrotechnical Commission, Geneva D IEC Medical electrical equipment - Part 1-6: General Requirements for Basic Safety and Essential Performance - Collateral Standard: Usability. International Electrotechnical Commission, Geneva E IEC Medical electrical equipment - Part 1-8: General Requirements for Basic Safety and Essential Performance - Collateral Standard: General Requirements, Tests and Guidance for Alarm Systems in Medical Electrical Equipment and Medical Electrical Systems, 2 nd ed. International Electrotechnical Commission, Geneva CAN J ANESTH 2007 / 54: 8 / pp From the Department of Anesthesia and Perioperative Medicine, Schulich School of Medicine and Dentistry, University of Western Ontario, London, Ontario, Canada. Address correspondence to: Dr. Steven Dain, Department of Anesthesia and Perioperative Medicine, Schulich School of Medicine and Dentistry, University of Western Ontario, Room C3-107, 339 Windermere Road, London, Ontario N6A 5A5, Canada. Phone: ; Fax: ;

2 614 CANADIAN JOURNAL OF ANESTHESIA There are several good books on the subject of usability testing that should be read by those evaluating and purchasing medical equipment. 3 Improving usability of anesthesia systems, and using a process as described in the recently published equipment usability standard, D will improve patient safety by reducing the incidence of human error related to equipment. Usability testing is now mandatory as a part of the risk management process in the development of all medical devices. The next technologically advanced change we will see in anesthesia systems is the use of physiological closed loop controllers (PCLC) for medication, fluid delivery and control of ventilation. Physiological closed loop controller systems, now available in parts of Europe, utilize inputs of one or more physiological parameters and by computer based algorithm determines one or more outputs. The loop is closed when the controlled output alters the measured input value which then feedbacks and further alters the output closing the loop. The underlying PCLC algorithm may include linear, non-linear, adaptive, or fuzzy logic control, or use neural networks. Standards for the design and validation of PCLC are forthcoming. F Information provided to the computer algorithm may include the patient s age, weight, height and gender in order for the computer to determine the optimal patient related physiological variables. Examples of PCLC include varying F I O 2 in response to a patient s SpO 2, specifying a target end-tidal CO 2 and allowing the anesthesia system to determine the ventilator settings, controlling optimizing propofol infusion rate in response to bispectral index or controlling the rate of infusion of muscle relaxant in response to a neuromuscular blockade monitor. Another algorithm maintains a set F I O 2 and endtidal anesthetic agent concentration by altering the fresh gas flows and the amount of anesthetic agent injected into the fresh gas targeting an age-related MAC value. Such algorithms determine the most efficient and cost-effective way to comfortably reach and maintain the preset values without causing large perturbations in the hemodynamics. With newer systems, instead of a conventional ventilator bellows delivering each breath, a piston or blower similar to those used in critical care ventilators are utilized. F Draft International Standard IEC Medical electrical equipment Part 1-10: General Requirements for Basic Safety and Essential Performance Collateral Standard: Requirements for the Development of Physiologic Closed-Loop Controllers. Recently, Ihmsen and colleagues 4 performed a teletherapeutic propofol infusion during total intravenous anesthesia with propofol in 11 patients undergoing general surgery in Erlangen, Germany. They used a processed electroencephalogram signal from patients to control an infusion pump using a computer located in Munich. They concluded Even if teleanaesthesia will probably not become routine in typical clinical settings, the presented system may serve as a model for remote drug therapy under special circumstances. Computer aided continuous infusion pumps have been readily available in Europe for a number of years. They employ mathematical models for frequently used drugs such as propofol, fentanyl, sufentanil, and remifentanil and can either be run independently or with the aid of a PCLC system. The anesthesiologist enters the patient s age and weight and gender and the target effect site concentration of drug desired. The pump varies the infusion rate to rapidly obtain and then maintain a constant effect site drug concentration which compensates for elimination of the drug and the movement of drug between the mathematical compartments. Infusion pumps will be integrated and networked into the anesthesia system, much like the vaporizer is today. However, we are unlikely to see equipment with PCLC in North America in the near future due to the regulatory obstacles and potential medical liability concerns. Manufacturers are also reluctant to market these devices here as the perceived mindset of the North American anesthesiologist will need to change from the FUD factor (fear, uncertainty and doubt) to one that is more accepting of automation. This is analogous to the initial distrust and now wide acceptance (and in fact dependence on) automated systems in aviation. As medical devices no longer work in isolation, means for interoperability in an integrated clinical environment have become necessary. The greatest impediment to future technological advances in anesthesia and critical care is the lack of a standardized communications protocol that will allow true plug and play device interoperability as we now have with our USB and fire wire consumer and business electronic devices. Unfortunately, these consumer protocols are not sufficiently robust for real-time medical applications. In the past 14 years since I lamented the need for a standardized protocol, G little usable, practical progress has been made. The family of ISO standards, (formerly IEEE 1073 Medical information bus) is too complex and too expensive to implement for simple devices. As clinicians we need simple to implement, usable device interoperability for the automated elec-

3 EDITORIAL 615 tronic anesthesia record, physiological closed loop control of anesthesia, integrated intelligent alarm systems, therapeutic decision support, control of portable imaging systems, and access to point of care diagnostic testing devices, both in the hospital and for homecare. Standardized extensible markup language based syntax and wired and wireless hardware solutions are needed. Standardization will reduce costs, remove implementation barriers, improve device interoperability and promote technological innovation. Recently, the Anesthesia Patient Safety Foundation stated: The APSF believes that intercommunication and interoperability of devices could lead to important advances in patient safety, and that the standards and protocols to allow such seamless intercommunication should be developed fully with these advances in mind. 5 The Medical Device Plug and Play Interoperability Program 6 (www.mdpnp.org) will guide the development and adoption of open standards and provides a vendor neutral laboratory to develop and evaluate proposed interoperability standards that will meet real world clinical requirements. The PnP Program is currently eliciting clinical scenarios from physicians of possible uses of device to device networking. The development of a standardized anesthesia terminology is currently underway by the International Organization for Terminology in Anesthesia in cooperation with the Systematized Nomenclature of Medicine. This will greatly reduce the costs of anesthesia information systems and facilitate compiling and sharing quality assurance information and research data for multicentre and multinational trials. Canada, being a relatively small country in the international marketplace (31.6 million persons) needs to be cognizant about which standards and which specific Canadian deviations will be required by Health Canada for licensure for use in this country. Compliance with Good manufacturing practice H and Risk Management I standards are required by the international regulatory agencies (Health Canada, US FDA, UK MDA, etc.). However, the application and use of all medical device standards must be consistent between countries. The Global Harmonization Task Force (GHTF) was conceived in 1992 in an effort to respond to the growing need for international harmonization in the regulation of medical devices. 7 It is a voluntary group of representatives from the national medical device regulatory authorities of Canada, United States, the European Union, United Kingdom and Japan and manufacturers and interested parties. Its goal is to devise a common framework for the requirements of licensure of medical devices and equipment so that manufacturers and distributors can minimize the amount of time, effort and cost of getting products to market. Although the national regulatory bodies, such as Health Canada and the Food and Drug Administration have a duty to protect the public, they must do so in a timely, efficient manner. Slow approvals and costly licensing deny individual citizens state of the art healthcare. Manufacturers and distributors of equipment often choose not to sell devices in small countries with high licensing costs as the return on investment may be inadequate to justify the expense of licensure. It is my hope that the GHTF will greatly streamline, simplify and reduce the cost of equipment licensing by having the common requirements and common paperwork for multiple nations, as opposed to the archaic, slow, stifling, expensive bureaucratic process used today. The healthcare industry is years behind in the use of information technology and expert systems that predominate in other industrial domains. Future work will describe and codify the patient-centric Integrated Clinical Environment with intent to develop a family of standards for network control of medical equipment, computers, video equipment and other ancillary equipment used in the hospital, telemedicine or home-care setting. This will aid in the advancement of automation in anesthesia and critical care analogous to the aircraft cockpit and air traffic control automation that has greatly improved aviation safety over the past 30 years. In the future, networked medical devices employing therapeutic decision support, physiological closed loop control for the administration of anesthetics, vasoactive agents and control of ventilation, self monitoring of medical device performance, intelligent alarms and secure encrypted information systems using standardized terminology in an integrated clinical environment will become commonplace. International standardization and governmental cooperation for the establishment of common multi- G Dain SL, Smith B. The need for standardization for computer to anaesthesia monitor communication protocols. Scientific Exhibit Annual Meeting of the American Society of Anesthesiologists. Washington D.C. October Anesthesiology Supplement S- 32 September H ISO 13485:2003 Medical devices -- Quality Management Systems -- Requirements for Regulatory Purposes. Organization for International Standardization, Geneva I ISO 14971:2007 Medical devices -- Application of Risk Management to Medical Devices. Organization for International Standardization, Geneva 2007.

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